DeviceClearance

Product code JLA— Clinical Chemistry

ASSERACHROM PROTEIN C KIT

Classification name
Conversion To Creatinine, Creatine
Device class
Class 1
Regulation
21 CFR 862.1210
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

Market context for product code JLA

FDA has cleared 2 devices under product code JLA, all in 1986, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code JLA

Recent clearances under product code JLA

Data sourced from openFDA. This site is unofficial and independent of the FDA.